DRAFT AGENDA, ver. 3, January 28, 2011

1

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

February 15-18, 2011

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ- OPP-2010-0588

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202 

Scientific Issues Related to Chlorpyrifos PBPK-PD Modeling Linked to CARES

Please note that all times are approximate 

(See note at the end of the Agenda)

Tuesday, February 15, 2011

9:00 A.M. Opening of Meeting and Administrative Procedures

Dr. Sharlene Matten, Designated Federal Official, Office of Science Coordination 

and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members 

Dr. Kenneth Portier, Chair, FIFRA Scientific Advisory Panel

9:10 A.M. Welcome and Opening Remarks 

Dr. Steven Bradbury, Director, Office of Pesticide Programs (OPP), EPA 

9:15 A.M. Introduction 

Dr. Tina Levine, Director, Health Effects Division, OPP, EPA

9:20 A.M. PBPK-PD Modeling in Risk Assessment

Health Effects Division, Speaker to be announced

10:00 A.M. BREAK
DRAFT AGENDA, ver. 3, January 28, 2011

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10:15 A.M. Overview of Modeling Approach, Chlorpyrifos Metabolism and Mode of 

Action, New Enzyme Data 

Dr. Mike Bartels, Dow Agrosciences

11:00 A.M. Description of the PBPK/PD Model, Development of the Lifestage Model

Dr. Torka Poet, Pacific Northwest National Laboratory

12:00 P.M. LUNCH

1:00 P.M. Description of the Variation Model 

Dr. Paul Hinderliter, Pacific Northwest National Laboratory

2:00 P.M. Source-to-Outcome Modeling 

Mr. Paul Price, Dow AgroSciences

3:00 P.M. BREAK

3:15 P.M. Utility of New Animal Study Data for Model Development

Dr. Sue Marty, Dow AgroSciences

4:00 P.M. Use of Model Predictions in the Risk Assessment Process

Mr. Paul Price, Dow AgroSciences

5:30 P.M. Adjourn
DRAFT AGENDA, ver. 3, January 28, 2011

3

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

February 15-18, 2011

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ- OPP-2010-0588

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202 

Scientific Issues Related to Chlorpyrifos PBPK-PD Modeling Linked to CARES 

Please note that all times are approximate 

(See note at the end of the Agenda)

Wednesday, February 16, 2011

9:00 A.M. Opening of Meeting and Administrative Procedures 

Dr. Sharlene Matten, Designated Federal Official, Office of Science Coordination 

and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members 

Dr. Kenneth Portier, Chair, FIFRA Scientific Advisory Panel

9:10 A.M. Follow-up from Previous Day’s Discussion

Health Effects Division, OPP, EPA

9:30 A.M. PUBLIC COMMENTS

10:15 A.M. BREAK

12:00 P.M. LUNCH

1:00 P.M. CHARGE QUESTIONS

Charge Question 1: Physiologically-Based 

Pharmacokinetic/Pharmacodynamic (PBPK/PD) Modeling
DRAFT AGENDA, ver. 3, January 28, 2011

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3:00 P.M. BREAK

3:15 P.M. Charge Question 2: Longitudinal Dietary Exposure Assessment

5:30 P.M. Adjourn
DRAFT AGENDA, ver. 3, January 28, 2011

5

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

February 15-18, 2011

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ- OPP-2010-0588

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202 

Scientific Issues Related to Chlorpyrifos PBPK-PD Modeling Linked to CARES 

Please note that all times are approximate 

(See note at the end of the Agenda)

Thursday, February 17, 2011

9:00 A.M. Opening of Meeting and Administrative Procedures 

Dr. Sharlene Matten, Designated Federal Official, Office of Science Coordination 

and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members 

Dr. Kenneth Portier, Chair, FIFRA Scientific Advisory Panel

9:10 A.M. Follow-up from Previous Day’s Discussion

Health Effects Division, OPP, EPA

9:30 A.M. Charge Question 3: Model Calibration and Evaluation with Direct Dosing 

Human Studies

10:15 A.M. BREAK

10:30 A.M. Charge Question 4: Comparison of Model Predictions with Human 

Monitoring Data

12:00 P.M. LUNCH

1:00 P.M. Charge Question 5: Sensitivity Analyses, Variability, and Uncertainty
DRAFT AGENDA, ver. 3, January 28, 2011

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3:00 P.M. BREAK

3:15 P.M. Charge Question 6: Calculating Data-Derived Extrapolation Factors

5:30 P.M. ADJOURN
DRAFT AGENDA, ver. 3, January 28, 2011

7

AGENDA

FIFRA SCIENTIFIC ADVISORY PANEL (SAP)

OPEN MEETING

February 15-18, 2011

FIFRA SAP WEB SITE http://www.epa.gov/scipoly/sap/

OPP Docket Telephone: (703) 305-5805

Docket Number: EPA-HQ- OPP-2010-0588

U.S. Environmental Protection Agency

Conference Center - Lobby Level

One Potomac Yard (South Bldg.)

2777 S. Crystal Drive, Arlington, VA 22202 

Scientific Issues Related to Chlorpyrifos PBPK-PD Modeling Linked to CARES 

Please note that all times are approximate 

(See note at the end of the Agenda)

Friday, February 18, 2011 (if needed)

9:00 A.M. Opening of Meeting and Administrative Procedures 

Dr. Sharlene Matten, Designated Federal Official, Office of Science Coordination 

and Policy, EPA

9:05 A.M. Introduction and Identification of Panel Members 

Dr. Kenneth Portier, Chair, FIFRA Scientific Advisory Panel

9:10 A.M. Follow-up from Previous Day’s Discussion 

Health Effects Division, OPP, EPA

9:30 A.M. Charge Questions continued

10:15 A.M. BREAK

10:30 A.M. Charge Questions continued

12:00 P.M. ADJOURN

Please be advised that agenda times are approximate; when the discussion for one topic is completed, 

discussions for the next topic will begin. For further information, please contact the Designated Federal 

Official for this meeting, Dr. Sharlene Matten, via telephone: (202)-564-0130; fax: (202) 564-8382; or 

email: matten.sharlene@epa.gov.